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Comparatively few biologic drugs are making it to the market, and many of those are for rare diseases, writes Nick Terrett, chief science officer at Ensemble Therapeutics. Part of the reason is the difficulty of developing biologic drugs, but the industry could use a paradigm shift in how it develops drugs, Terrett writes. Combining small-molecules and biologics could create a new therapy option, the macrocycle, he writes.

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Gilead Sciences will use Polyphor's macrocycle platform to discover and develop macrocycle drugs that address selected "challenging biological" targets through a collaboration and licensing agreement. Polyphor is entitled to an undisclosed upfront payment, research funding and milestone payments.

The FDA's new Oncology Center of Excellence, under the leadership of Richard Pazdur, will coordinate review and approval of drugs, diagnostic tests, cell therapies and other new technologies that will result from national initiatives to cure cancer. The FDA is preparing for a flood of new products, not all of which will work, say Pazdur and FDA Commissioner Robert Califf.

Biologics, which are treatments derived from biological sources, represent five of the 10 highest-selling drugs last year, underscoring their rapid rise. Loss of patent protection for some top biologics is expected to drive sales of biosimilar drugs in coming years.

President Barack Obama said in his State of the Union address that automatic budget cuts would "gut job-creating investments in science and innovation," and Onyx Pharmaceuticals CEO Tony Coles agrees. Onyx's liver and kidney cancer drug Nexavar would never have been invented without numerous NIH grants, which have a six-to-one return, Coles says. Even a small budget cut could drive young researchers out of the science field, and new projects would never get under way, Matthew Herper writes.

Former NIH Director Elias Zerhouni, now Sanofi's research and development chief, is shifting the drugmaker's R&D focus to understanding the biology of diseases. Novartis and Roche Holding have made similar moves to gain a better understanding of how diseases work in an effort to find drug targets.